Data / Medical devices / United States / Urologix, LLC

Urologix, LLC: FDA-registered device maker in Plymouth, MN, United States, 1 510(k) clearance and 1 PMA approval

Name: Urologix, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Urologix, LLC is registered with the FDA (registration 2133936) in Plymouth, MN, United States. It lists 3 device types. The FDA files 1 510(k) clearance and 1 PMA approval under its listings, the newest dated November 15, 2012. 5 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 2133936
FEI number: 3000718675
Address: 13355 10th Ave N. Suite 110, Plymouth, MN, United States, 55441
Owner or operator: Urologix LLC (10051240)
Roles: Manufacturer, Remanufacturer
First device listed: February 22, 2016
Registered through: 2026
Brand names listed: Coolwave, Electrosurgical, Cutting & Coagulation & Accessories - Prostiva; Electrosurgical, Cutting & Coagulation & Accessories -, Targis

Devices it lists

Device	Product code	Class	Role	Source
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Manufacturer	accessdata.fda.gov
System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy	MEQ	3	Manufacturer, Remanufacturer	accessdata.fda.gov
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	KNS	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
November 15, 2012	K113380	PROSTIVA RF THERAPY HAND PIECE PROSTIVA RF THERAPY RF GENERATOR	GEI	Substantially Equivalent	Medtronic, Inc.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
August 22, 1997	P970008	TARGIS (T3) SYSTEM	MEQ	62	October 29, 2015	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
October 21, 2013	66598	Class II	Terminated	Prostiva RF Therapy Hand Piece Kit, REF 8929, Rx only, sterilized using Ethylene Oxide. The Prostiva RF Model 8929 Hand Piece Kit is the delivery system component of the Prostiva RF Therapy System. Prostiva RF Therapy de	A Hand Piece high deployment force exceeded the maximum specification.	accessdata.fda.gov
April 28, 2011	58695	Not yet classified	Terminated	The following kits contain the UROLOGIX, Coolant Bag, CA1111B, Sterile EO, Manufactured for: UROLOGIX, Inc., 14405 Twenty-first Avenue North, Minneapolis, MN 55447. UROLOGIX, CTC Advance Short, (2.5-3.5 cm), PT1034, Ster	Urologix is recalling certain lots of Targis System Coolant Bag devices distributed over a two week period. The devices are packaged into disposable Procedure Kits containing a microwave catheter, a Coolant Bag and a RTU Plus balloon. The reason for this Recall involves three lots of Coolant Bags that contain an increased risk of leakage of water at the Sens	accessdata.fda.gov
February 18, 2010	54703	Not yet classified	Terminated	UROLOGIX CTC Advance" Standard Microwave Catheter (3.0-5.0 cm), CTC Advance" Long Microwave Catheter (4.5+ cm), CTC Advance" Short Microwave Catheter (2.5 -3.5 cm), RTU Plus Balloon, and RTU Plus Handle, Sterile EO, Manu	Urolgix is recalling certain lots of CTC Advance" catheters and RTU Plus devices which are integral components of the Targis System. The reason for this Recall is a labeling error only; the issue involves a discrepancy in the"Use Before" date printed on the product label. In the affected lots, the "Use Before" date, commonly known as the expiration date, is	accessdata.fda.gov
March 16, 2007	37638	Not yet classified	Terminated	Urologix Microwave Delivery System 3.0 - 5.0. For use with prostatic urethra lengths of 3.0-5.0 cm only. Model TA1121D.	The catheter in the kit matches the description on the kit and pouch label; however, an incorrect label was placed onto the catheter during manufacturing.	accessdata.fda.gov
December 10, 2003	27983	Not yet classified	Terminated	Prostatron Praktis Type II for Transurethral Microwave Thermotherapy. The Prostatron is a computer-controlled device designed to deliver microwave energy to the prostrate for the treatment of BPH (Benign Prostatic Hyperp	During treatments, using the Prostatron units, the devices' Temperature Sensing System may change the rectal temperature reading by up to 2 degrees Celsius and may briefly delay updates to the rectal temperature reading.	accessdata.fda.gov

Compare with other makers

Updated October 29, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.